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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 021356


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NDA 021356 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 021356
Tradename:VIREAD
Applicant:Gilead Sciences Inc
Ingredient:tenofovir disoproxil fumarate
Patents:0
Pharmacology for NDA: 021356
Suppliers and Packaging for NDA: 021356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356 NDA Gilead Sciences, Inc. 61958-0401 61958-0401-1 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1)
VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356 NDA Gilead Sciences, Inc. 61958-0404 61958-0404-1 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 26, 2001TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 18, 2012TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 18, 2012TE:ABRLD:Yes

Expired US Patents for NDA 021356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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